Imiquimod for anogenital warts in non‐immunocompromised adults
Background 30% of people with anogenital warts (AGW) have spontaneous regression of lesions but there is no way to determine whether a specific lesion will remain. There are a wide range of options available for treating people with AGW and selection is based on clinician's experience, patient...
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| Veröffentlicht in: | Cochrane database of systematic reviews 2014-11, Vol.2014 (11), p.CD010389 |
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| creator | Grillo‐Ardila, Carlos F Angel‐Müller, Edith Salazar‐Díaz, Luis C Gaitán, Hernando G Ruiz‐Parra, Ariel I Lethaby, Anne Grillo‐Ardila, Carlos F |
| description | Background
30% of people with anogenital warts (AGW) have spontaneous regression of lesions but there is no way to determine whether a specific lesion will remain. There are a wide range of options available for treating people with AGW and selection is based on clinician's experience, patient preferences and adverse effects. The imiquimod could offer the advantages of patient‐applied therapies without incurring the limitations of provider‐administered treatments.
Objectives
To assess the effectiveness and safety of imiquimod for the treatment of AGW in non‐immunocompromised adults.
Search methods
We searched the Cochrane Sexually Transmitted Infections Group Specialized Register (15 April 2014), CENTRAL (1991 to 15 April 2014), MEDLINE (1946 to 15 April 2014), EMBASE (1947 to 15 April 2014), LILACS (1982 to 15 April 2014), World Health Organization International Clinical Trials Registry (ICTRP) (15 April 2014), ClinicalTrials.gov (15 April 2014), Web of Science (2001 to 15 April 2014) and OpenGrey (15 April 2014). We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies.
Selection criteria
Randomized controlled trials (RCTs) comparing the use of imiquimod with placebo, any other patient‐applied or any other provider‐administered treatment (excluding interferon and 5‐fluorouracil which are assessed in other Cochrane Reviews) for the treatment of AGW in non‐immunocompromised adults.
Data collection and analysis
Three review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We resolved any disagreements through consensus. The quality of the evidence was assessed using the GRADE approach.
Main results
Ten RCTs (1734 participants) met our inclusion criteria of which six were funded by industry. We judged the risk of bias of the included trials as high. Six trials (1294 participants) compared the use of imiquimod versus placebo. There was very low quality evidence that imiquimod was superior to placebo in achieving complete and partial regression (RR 4.03, 95% CI 2.03 to 7.99; RR 2.56, 95% CI 2.05 to 3.20, respectively). When compared with placebo, the effects of imiquimod on recurrence (RR 2.76, 95% CI 0.70 to 10.91), appearance of new warts (RR 0.76, 95% CI 0.58 to 1.00) and frequency of systemic adverse reactions (RR 0.91, 95% CI 0.63 to 1.32) were imprecise. We downgraded the quality of evidence to low or very low. There was low quality evidence th |
| doi_str_mv | 10.1002/14651858.CD010389.pub2 |
| format | Article |
| fullrecord | <record><control><sourceid>wiley_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10777270</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>CD010389.pub2</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4262-82bf46a333781f8c34053a215f4c97dc63705373276d25441e3cd0034bbf4183</originalsourceid><addsrcrecordid>eNqFkEtOwzAQhi0EoqVwhSoXaPErdrLiUV6VKrHp3nIdpzWK7WInoO44AmfkJCQqrQobVmPNP_834x-AIYJjBCG-RJSlKEuz8eQOIkiyfLxuFvgI9Dth1CnHB-8eOIvxBULCcsxPQQ-nhGGM8z64nlrz2hjri6T0IZHOL7UztaySdxnqmBiXOO--Pj6NtY3zytt18NZEXSSyaKo6noOTUlZRX_zUAZg_3M8nT6PZ8-N0cjMbKYoZHmV4UVImCSE8Q2WmCIUpkRilJVU5LxQjvG1wgjkrcEop0kQV7cF00fpQRgbgaottv2l1obSrg6zEOhgrw0Z4acRvxZmVWPo3gSDnHHPYEtiWoIKPMehyb0ZQdJmKXaZil2mHxK1xeLh6b9uF2A7cbgfeTaU3Qnm1CtLpf7h_tnwDvWOIxw</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>Imiquimod for anogenital warts in non‐immunocompromised adults</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><source>Cochrane Library</source><creator>Grillo‐Ardila, Carlos F ; Angel‐Müller, Edith ; Salazar‐Díaz, Luis C ; Gaitán, Hernando G ; Ruiz‐Parra, Ariel I ; Lethaby, Anne ; Grillo‐Ardila, Carlos F</creator><creatorcontrib>Grillo‐Ardila, Carlos F ; Angel‐Müller, Edith ; Salazar‐Díaz, Luis C ; Gaitán, Hernando G ; Ruiz‐Parra, Ariel I ; Lethaby, Anne ; Grillo‐Ardila, Carlos F</creatorcontrib><description>Background
30% of people with anogenital warts (AGW) have spontaneous regression of lesions but there is no way to determine whether a specific lesion will remain. There are a wide range of options available for treating people with AGW and selection is based on clinician's experience, patient preferences and adverse effects. The imiquimod could offer the advantages of patient‐applied therapies without incurring the limitations of provider‐administered treatments.
Objectives
To assess the effectiveness and safety of imiquimod for the treatment of AGW in non‐immunocompromised adults.
Search methods
We searched the Cochrane Sexually Transmitted Infections Group Specialized Register (15 April 2014), CENTRAL (1991 to 15 April 2014), MEDLINE (1946 to 15 April 2014), EMBASE (1947 to 15 April 2014), LILACS (1982 to 15 April 2014), World Health Organization International Clinical Trials Registry (ICTRP) (15 April 2014), ClinicalTrials.gov (15 April 2014), Web of Science (2001 to 15 April 2014) and OpenGrey (15 April 2014). We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies.
Selection criteria
Randomized controlled trials (RCTs) comparing the use of imiquimod with placebo, any other patient‐applied or any other provider‐administered treatment (excluding interferon and 5‐fluorouracil which are assessed in other Cochrane Reviews) for the treatment of AGW in non‐immunocompromised adults.
Data collection and analysis
Three review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We resolved any disagreements through consensus. The quality of the evidence was assessed using the GRADE approach.
Main results
Ten RCTs (1734 participants) met our inclusion criteria of which six were funded by industry. We judged the risk of bias of the included trials as high. Six trials (1294 participants) compared the use of imiquimod versus placebo. There was very low quality evidence that imiquimod was superior to placebo in achieving complete and partial regression (RR 4.03, 95% CI 2.03 to 7.99; RR 2.56, 95% CI 2.05 to 3.20, respectively). When compared with placebo, the effects of imiquimod on recurrence (RR 2.76, 95% CI 0.70 to 10.91), appearance of new warts (RR 0.76, 95% CI 0.58 to 1.00) and frequency of systemic adverse reactions (RR 0.91, 95% CI 0.63 to 1.32) were imprecise. We downgraded the quality of evidence to low or very low. There was low quality evidence that imiquimod led to more local adverse reactions (RR 1.73, 95% CI 1.18 to 2.53) and pain (RR 11.84, 95% CI 3.36 to 41.63).
Two trials (105 participants) compared the use of imiquimod versus any other patient‐applied treatment (podophyllotoxin and podophyllin). The estimated effects of imiquimod on complete regression (RR 1.09, 95% CI 0.80 to 1.48), partial regression (RR 0.77, 95% CI 0.40 to 1.47), recurrence (RR 0.49, 95% CI 0.21 to 1.11) or the presence of local adverse reactions (RR 1.24, 95% CI 1.00 to 1.54) were imprecise (very low quality evidence). There was low quality evidence that systemic adverse reactions were less frequent with imiquimod (RR 0.30, 95% CI 0.09 to 0.98).
Finally, two trials (335 participants) compared imiquimod with any other provider‐administered treatment (ablative methods and cryotherapy). There was very low quality of evidence that imiquimod did not have a lower frequency of complete regression (RR 0.84, 95% CI 0.56 to 1.28). There was very low quality evidence that imiquimod led to a lower rate of recurrence during six‐month follow‐up (RR 0.24, 95% CI 0.10 to 0.56) but this did not translate in to a lower recurrence from six to 12 months (RR 0.71, 95% CI 0.40 to 1.25; very low quality evidence). There was very low quality evidence that imiquimod was associated with less pain (RR 0.30, 95% CI 0.17 to 0.54) and fewer local reactions (RR 0.55, 95% CI 0.40 to 0.74).
Authors' conclusions
The benefits and harms of imiquimod compared with placebo should be regarded with caution due to the risk of bias, imprecision and inconsistency for many of the outcomes we assessed in this Cochrane Review. The evidence for many of the outcomes that show imiquimod and patient‐applied treatment (podophyllotoxin or podophyllin) confer similar benefits but fewer systematic reactions with the Imiquimod, is of low or very low quality. The quality of evidence for the outcomes assessing imiquimod and other provider‐administered treatment were of very low quality.</description><identifier>ISSN: 1465-1858</identifier><identifier>EISSN: 1465-1858</identifier><identifier>EISSN: 1469-493X</identifier><identifier>DOI: 10.1002/14651858.CD010389.pub2</identifier><identifier>PMID: 25362229</identifier><language>eng</language><publisher>Chichester, UK: John Wiley & Sons, Ltd</publisher><subject>Adult ; Aminoquinolines ; Aminoquinolines - adverse effects ; Aminoquinolines - therapeutic use ; Anus Diseases ; Anus Diseases - drug therapy ; Anus Diseases - virology ; Female ; Genital Diseases, Female ; Genital Diseases, Female - drug therapy ; Genital Diseases, Female - virology ; Genital Diseases, Male ; Genital Diseases, Male - drug therapy ; Genital Diseases, Male - virology ; Genital warts ; Gynaecology ; Humans ; Imiquimod ; Immunocompetence ; Infections ; Infectious disease ; Interferon Inducers ; Interferon Inducers - adverse effects ; Interferon Inducers - therapeutic use ; Keratolytic Agents ; Keratolytic Agents - therapeutic use ; Male ; Medicine General & Introductory Medical Sciences ; Podophyllin ; Podophyllin - therapeutic use ; Podophyllotoxin ; Podophyllotoxin - therapeutic use ; Randomized Controlled Trials as Topic ; Recurrence ; Self Administration ; Sexually transmitted disease ; Skin disorders ; Skin infections ; Treatment ; Treatment of viral infections ; Warts ; Warts - drug therapy</subject><ispartof>Cochrane database of systematic reviews, 2014-11, Vol.2014 (11), p.CD010389</ispartof><rights>Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4262-82bf46a333781f8c34053a215f4c97dc63705373276d25441e3cd0034bbf4183</citedby><cites>FETCH-LOGICAL-c4262-82bf46a333781f8c34053a215f4c97dc63705373276d25441e3cd0034bbf4183</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25362229$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Grillo‐Ardila, Carlos F</creatorcontrib><creatorcontrib>Angel‐Müller, Edith</creatorcontrib><creatorcontrib>Salazar‐Díaz, Luis C</creatorcontrib><creatorcontrib>Gaitán, Hernando G</creatorcontrib><creatorcontrib>Ruiz‐Parra, Ariel I</creatorcontrib><creatorcontrib>Lethaby, Anne</creatorcontrib><creatorcontrib>Grillo‐Ardila, Carlos F</creatorcontrib><title>Imiquimod for anogenital warts in non‐immunocompromised adults</title><title>Cochrane database of systematic reviews</title><addtitle>Cochrane Database Syst Rev</addtitle><description>Background
30% of people with anogenital warts (AGW) have spontaneous regression of lesions but there is no way to determine whether a specific lesion will remain. There are a wide range of options available for treating people with AGW and selection is based on clinician's experience, patient preferences and adverse effects. The imiquimod could offer the advantages of patient‐applied therapies without incurring the limitations of provider‐administered treatments.
Objectives
To assess the effectiveness and safety of imiquimod for the treatment of AGW in non‐immunocompromised adults.
Search methods
We searched the Cochrane Sexually Transmitted Infections Group Specialized Register (15 April 2014), CENTRAL (1991 to 15 April 2014), MEDLINE (1946 to 15 April 2014), EMBASE (1947 to 15 April 2014), LILACS (1982 to 15 April 2014), World Health Organization International Clinical Trials Registry (ICTRP) (15 April 2014), ClinicalTrials.gov (15 April 2014), Web of Science (2001 to 15 April 2014) and OpenGrey (15 April 2014). We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies.
Selection criteria
Randomized controlled trials (RCTs) comparing the use of imiquimod with placebo, any other patient‐applied or any other provider‐administered treatment (excluding interferon and 5‐fluorouracil which are assessed in other Cochrane Reviews) for the treatment of AGW in non‐immunocompromised adults.
Data collection and analysis
Three review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We resolved any disagreements through consensus. The quality of the evidence was assessed using the GRADE approach.
Main results
Ten RCTs (1734 participants) met our inclusion criteria of which six were funded by industry. We judged the risk of bias of the included trials as high. Six trials (1294 participants) compared the use of imiquimod versus placebo. There was very low quality evidence that imiquimod was superior to placebo in achieving complete and partial regression (RR 4.03, 95% CI 2.03 to 7.99; RR 2.56, 95% CI 2.05 to 3.20, respectively). When compared with placebo, the effects of imiquimod on recurrence (RR 2.76, 95% CI 0.70 to 10.91), appearance of new warts (RR 0.76, 95% CI 0.58 to 1.00) and frequency of systemic adverse reactions (RR 0.91, 95% CI 0.63 to 1.32) were imprecise. We downgraded the quality of evidence to low or very low. There was low quality evidence that imiquimod led to more local adverse reactions (RR 1.73, 95% CI 1.18 to 2.53) and pain (RR 11.84, 95% CI 3.36 to 41.63).
Two trials (105 participants) compared the use of imiquimod versus any other patient‐applied treatment (podophyllotoxin and podophyllin). The estimated effects of imiquimod on complete regression (RR 1.09, 95% CI 0.80 to 1.48), partial regression (RR 0.77, 95% CI 0.40 to 1.47), recurrence (RR 0.49, 95% CI 0.21 to 1.11) or the presence of local adverse reactions (RR 1.24, 95% CI 1.00 to 1.54) were imprecise (very low quality evidence). There was low quality evidence that systemic adverse reactions were less frequent with imiquimod (RR 0.30, 95% CI 0.09 to 0.98).
Finally, two trials (335 participants) compared imiquimod with any other provider‐administered treatment (ablative methods and cryotherapy). There was very low quality of evidence that imiquimod did not have a lower frequency of complete regression (RR 0.84, 95% CI 0.56 to 1.28). There was very low quality evidence that imiquimod led to a lower rate of recurrence during six‐month follow‐up (RR 0.24, 95% CI 0.10 to 0.56) but this did not translate in to a lower recurrence from six to 12 months (RR 0.71, 95% CI 0.40 to 1.25; very low quality evidence). There was very low quality evidence that imiquimod was associated with less pain (RR 0.30, 95% CI 0.17 to 0.54) and fewer local reactions (RR 0.55, 95% CI 0.40 to 0.74).
Authors' conclusions
The benefits and harms of imiquimod compared with placebo should be regarded with caution due to the risk of bias, imprecision and inconsistency for many of the outcomes we assessed in this Cochrane Review. The evidence for many of the outcomes that show imiquimod and patient‐applied treatment (podophyllotoxin or podophyllin) confer similar benefits but fewer systematic reactions with the Imiquimod, is of low or very low quality. The quality of evidence for the outcomes assessing imiquimod and other provider‐administered treatment were of very low quality.</description><subject>Adult</subject><subject>Aminoquinolines</subject><subject>Aminoquinolines - adverse effects</subject><subject>Aminoquinolines - therapeutic use</subject><subject>Anus Diseases</subject><subject>Anus Diseases - drug therapy</subject><subject>Anus Diseases - virology</subject><subject>Female</subject><subject>Genital Diseases, Female</subject><subject>Genital Diseases, Female - drug therapy</subject><subject>Genital Diseases, Female - virology</subject><subject>Genital Diseases, Male</subject><subject>Genital Diseases, Male - drug therapy</subject><subject>Genital Diseases, Male - virology</subject><subject>Genital warts</subject><subject>Gynaecology</subject><subject>Humans</subject><subject>Imiquimod</subject><subject>Immunocompetence</subject><subject>Infections</subject><subject>Infectious disease</subject><subject>Interferon Inducers</subject><subject>Interferon Inducers - adverse effects</subject><subject>Interferon Inducers - therapeutic use</subject><subject>Keratolytic Agents</subject><subject>Keratolytic Agents - therapeutic use</subject><subject>Male</subject><subject>Medicine General & Introductory Medical Sciences</subject><subject>Podophyllin</subject><subject>Podophyllin - therapeutic use</subject><subject>Podophyllotoxin</subject><subject>Podophyllotoxin - therapeutic use</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Recurrence</subject><subject>Self Administration</subject><subject>Sexually transmitted disease</subject><subject>Skin disorders</subject><subject>Skin infections</subject><subject>Treatment</subject><subject>Treatment of viral infections</subject><subject>Warts</subject><subject>Warts - drug therapy</subject><issn>1465-1858</issn><issn>1465-1858</issn><issn>1469-493X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>RWY</sourceid><sourceid>EIF</sourceid><recordid>eNqFkEtOwzAQhi0EoqVwhSoXaPErdrLiUV6VKrHp3nIdpzWK7WInoO44AmfkJCQqrQobVmPNP_834x-AIYJjBCG-RJSlKEuz8eQOIkiyfLxuFvgI9Dth1CnHB-8eOIvxBULCcsxPQQ-nhGGM8z64nlrz2hjri6T0IZHOL7UztaySdxnqmBiXOO--Pj6NtY3zytt18NZEXSSyaKo6noOTUlZRX_zUAZg_3M8nT6PZ8-N0cjMbKYoZHmV4UVImCSE8Q2WmCIUpkRilJVU5LxQjvG1wgjkrcEop0kQV7cF00fpQRgbgaottv2l1obSrg6zEOhgrw0Z4acRvxZmVWPo3gSDnHHPYEtiWoIKPMehyb0ZQdJmKXaZil2mHxK1xeLh6b9uF2A7cbgfeTaU3Qnm1CtLpf7h_tnwDvWOIxw</recordid><startdate>20141101</startdate><enddate>20141101</enddate><creator>Grillo‐Ardila, Carlos F</creator><creator>Angel‐Müller, Edith</creator><creator>Salazar‐Díaz, Luis C</creator><creator>Gaitán, Hernando G</creator><creator>Ruiz‐Parra, Ariel I</creator><creator>Lethaby, Anne</creator><creator>Grillo‐Ardila, Carlos F</creator><general>John Wiley & Sons, Ltd</general><scope>7PX</scope><scope>RWY</scope><scope>ZYTZH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>5PM</scope></search><sort><creationdate>20141101</creationdate><title>Imiquimod for anogenital warts in non‐immunocompromised adults</title><author>Grillo‐Ardila, Carlos F ; Angel‐Müller, Edith ; Salazar‐Díaz, Luis C ; Gaitán, Hernando G ; Ruiz‐Parra, Ariel I ; Lethaby, Anne ; Grillo‐Ardila, Carlos F</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4262-82bf46a333781f8c34053a215f4c97dc63705373276d25441e3cd0034bbf4183</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Aminoquinolines</topic><topic>Aminoquinolines - adverse effects</topic><topic>Aminoquinolines - therapeutic use</topic><topic>Anus Diseases</topic><topic>Anus Diseases - drug therapy</topic><topic>Anus Diseases - virology</topic><topic>Female</topic><topic>Genital Diseases, Female</topic><topic>Genital Diseases, Female - drug therapy</topic><topic>Genital Diseases, Female - virology</topic><topic>Genital Diseases, Male</topic><topic>Genital Diseases, Male - drug therapy</topic><topic>Genital Diseases, Male - virology</topic><topic>Genital warts</topic><topic>Gynaecology</topic><topic>Humans</topic><topic>Imiquimod</topic><topic>Immunocompetence</topic><topic>Infections</topic><topic>Infectious disease</topic><topic>Interferon Inducers</topic><topic>Interferon Inducers - adverse effects</topic><topic>Interferon Inducers - therapeutic use</topic><topic>Keratolytic Agents</topic><topic>Keratolytic Agents - therapeutic use</topic><topic>Male</topic><topic>Medicine General & Introductory Medical Sciences</topic><topic>Podophyllin</topic><topic>Podophyllin - therapeutic use</topic><topic>Podophyllotoxin</topic><topic>Podophyllotoxin - therapeutic use</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Recurrence</topic><topic>Self Administration</topic><topic>Sexually transmitted disease</topic><topic>Skin disorders</topic><topic>Skin infections</topic><topic>Treatment</topic><topic>Treatment of viral infections</topic><topic>Warts</topic><topic>Warts - drug therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Grillo‐Ardila, Carlos F</creatorcontrib><creatorcontrib>Angel‐Müller, Edith</creatorcontrib><creatorcontrib>Salazar‐Díaz, Luis C</creatorcontrib><creatorcontrib>Gaitán, Hernando G</creatorcontrib><creatorcontrib>Ruiz‐Parra, Ariel I</creatorcontrib><creatorcontrib>Lethaby, Anne</creatorcontrib><creatorcontrib>Grillo‐Ardila, Carlos F</creatorcontrib><collection>Wiley-Blackwell Cochrane Library</collection><collection>Cochrane Library</collection><collection>Cochrane Library (Open Aceess)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cochrane database of systematic reviews</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Grillo‐Ardila, Carlos F</au><au>Angel‐Müller, Edith</au><au>Salazar‐Díaz, Luis C</au><au>Gaitán, Hernando G</au><au>Ruiz‐Parra, Ariel I</au><au>Lethaby, Anne</au><au>Grillo‐Ardila, Carlos F</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Imiquimod for anogenital warts in non‐immunocompromised adults</atitle><jtitle>Cochrane database of systematic reviews</jtitle><addtitle>Cochrane Database Syst Rev</addtitle><date>2014-11-01</date><risdate>2014</risdate><volume>2014</volume><issue>11</issue><spage>CD010389</spage><pages>CD010389-</pages><issn>1465-1858</issn><eissn>1465-1858</eissn><eissn>1469-493X</eissn><abstract>Background
30% of people with anogenital warts (AGW) have spontaneous regression of lesions but there is no way to determine whether a specific lesion will remain. There are a wide range of options available for treating people with AGW and selection is based on clinician's experience, patient preferences and adverse effects. The imiquimod could offer the advantages of patient‐applied therapies without incurring the limitations of provider‐administered treatments.
Objectives
To assess the effectiveness and safety of imiquimod for the treatment of AGW in non‐immunocompromised adults.
Search methods
We searched the Cochrane Sexually Transmitted Infections Group Specialized Register (15 April 2014), CENTRAL (1991 to 15 April 2014), MEDLINE (1946 to 15 April 2014), EMBASE (1947 to 15 April 2014), LILACS (1982 to 15 April 2014), World Health Organization International Clinical Trials Registry (ICTRP) (15 April 2014), ClinicalTrials.gov (15 April 2014), Web of Science (2001 to 15 April 2014) and OpenGrey (15 April 2014). We also handsearched conference proceedings, contacted trial authors and reviewed the reference lists of retrieved studies.
Selection criteria
Randomized controlled trials (RCTs) comparing the use of imiquimod with placebo, any other patient‐applied or any other provider‐administered treatment (excluding interferon and 5‐fluorouracil which are assessed in other Cochrane Reviews) for the treatment of AGW in non‐immunocompromised adults.
Data collection and analysis
Three review authors independently assessed trials for inclusion, extracted data and assessed risk of bias. We resolved any disagreements through consensus. The quality of the evidence was assessed using the GRADE approach.
Main results
Ten RCTs (1734 participants) met our inclusion criteria of which six were funded by industry. We judged the risk of bias of the included trials as high. Six trials (1294 participants) compared the use of imiquimod versus placebo. There was very low quality evidence that imiquimod was superior to placebo in achieving complete and partial regression (RR 4.03, 95% CI 2.03 to 7.99; RR 2.56, 95% CI 2.05 to 3.20, respectively). When compared with placebo, the effects of imiquimod on recurrence (RR 2.76, 95% CI 0.70 to 10.91), appearance of new warts (RR 0.76, 95% CI 0.58 to 1.00) and frequency of systemic adverse reactions (RR 0.91, 95% CI 0.63 to 1.32) were imprecise. We downgraded the quality of evidence to low or very low. There was low quality evidence that imiquimod led to more local adverse reactions (RR 1.73, 95% CI 1.18 to 2.53) and pain (RR 11.84, 95% CI 3.36 to 41.63).
Two trials (105 participants) compared the use of imiquimod versus any other patient‐applied treatment (podophyllotoxin and podophyllin). The estimated effects of imiquimod on complete regression (RR 1.09, 95% CI 0.80 to 1.48), partial regression (RR 0.77, 95% CI 0.40 to 1.47), recurrence (RR 0.49, 95% CI 0.21 to 1.11) or the presence of local adverse reactions (RR 1.24, 95% CI 1.00 to 1.54) were imprecise (very low quality evidence). There was low quality evidence that systemic adverse reactions were less frequent with imiquimod (RR 0.30, 95% CI 0.09 to 0.98).
Finally, two trials (335 participants) compared imiquimod with any other provider‐administered treatment (ablative methods and cryotherapy). There was very low quality of evidence that imiquimod did not have a lower frequency of complete regression (RR 0.84, 95% CI 0.56 to 1.28). There was very low quality evidence that imiquimod led to a lower rate of recurrence during six‐month follow‐up (RR 0.24, 95% CI 0.10 to 0.56) but this did not translate in to a lower recurrence from six to 12 months (RR 0.71, 95% CI 0.40 to 1.25; very low quality evidence). There was very low quality evidence that imiquimod was associated with less pain (RR 0.30, 95% CI 0.17 to 0.54) and fewer local reactions (RR 0.55, 95% CI 0.40 to 0.74).
Authors' conclusions
The benefits and harms of imiquimod compared with placebo should be regarded with caution due to the risk of bias, imprecision and inconsistency for many of the outcomes we assessed in this Cochrane Review. The evidence for many of the outcomes that show imiquimod and patient‐applied treatment (podophyllotoxin or podophyllin) confer similar benefits but fewer systematic reactions with the Imiquimod, is of low or very low quality. The quality of evidence for the outcomes assessing imiquimod and other provider‐administered treatment were of very low quality.</abstract><cop>Chichester, UK</cop><pub>John Wiley & Sons, Ltd</pub><pmid>25362229</pmid><doi>10.1002/14651858.CD010389.pub2</doi><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1465-1858 |
| ispartof | Cochrane database of systematic reviews, 2014-11, Vol.2014 (11), p.CD010389 |
| issn | 1465-1858 1465-1858 1469-493X |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_10777270 |
| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection; Cochrane Library |
| subjects | Adult Aminoquinolines Aminoquinolines - adverse effects Aminoquinolines - therapeutic use Anus Diseases Anus Diseases - drug therapy Anus Diseases - virology Female Genital Diseases, Female Genital Diseases, Female - drug therapy Genital Diseases, Female - virology Genital Diseases, Male Genital Diseases, Male - drug therapy Genital Diseases, Male - virology Genital warts Gynaecology Humans Imiquimod Immunocompetence Infections Infectious disease Interferon Inducers Interferon Inducers - adverse effects Interferon Inducers - therapeutic use Keratolytic Agents Keratolytic Agents - therapeutic use Male Medicine General & Introductory Medical Sciences Podophyllin Podophyllin - therapeutic use Podophyllotoxin Podophyllotoxin - therapeutic use Randomized Controlled Trials as Topic Recurrence Self Administration Sexually transmitted disease Skin disorders Skin infections Treatment Treatment of viral infections Warts Warts - drug therapy |
| title | Imiquimod for anogenital warts in non‐immunocompromised adults |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-19T14%3A00%3A48IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-wiley_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Imiquimod%20for%20anogenital%20warts%20in%20non%E2%80%90immunocompromised%20adults&rft.jtitle=Cochrane%20database%20of%20systematic%20reviews&rft.au=Grillo%E2%80%90Ardila,%20Carlos%20F&rft.date=2014-11-01&rft.volume=2014&rft.issue=11&rft.spage=CD010389&rft.pages=CD010389-&rft.issn=1465-1858&rft.eissn=1465-1858&rft_id=info:doi/10.1002/14651858.CD010389.pub2&rft_dat=%3Cwiley_pubme%3ECD010389.pub2%3C/wiley_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_id=info:pmid/25362229&rfr_iscdi=true |